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NOVOEIGHT
Bleeding disorders
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Drug Name:

NOVOEIGHT Rx

Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Company:
Novo Nordisk

Therapeutic Use:

Indications for NOVOEIGHT:

In patients with Hemophilia A: for control and prevention of bleeding, for perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.

Adults and Children:

Dosage Required (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % of Normal) × 0.5 (IU/kg per IU/dL). Inject slowly over 2–5 mins. Bleeding: Minor: obtain 20–40% FVIII increase; give every 12–24hrs for ≥1 day until resolved. Moderate: obtain 30–60% FVIII increase; give every 12–24hrs for 3–4 days until resolved. Major: obtain 60–100% FVIII increase; give every 8–24hrs for 7–10 days until resolved. Perioperative: Minor: obtain 30–60% FVIII increase; give every 24hrs for ≥1 day until healed. Major (pre- and post-op): obtain 80–100% FVIII increase every 8–24hrs until adequate wound healing, then continue for ≥7 days to maintain FVIII activity of 30–60%. Routine prophylaxis: <12yrs: give 25–60 IU/kg 3 times weekly or 25–50 IU/kg every other day; ≥12yrs: give 20–50 IU/kg 3 times weekly or 20–40 IU/kg every other day. Adjust based on response.

Contraindications:

Hamster protein sensitivity.

Warnings/Precautions:

Not for von Willebrand's disease. Monitor for development of Factor VIII inhibitors. Immediately discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Inj site reactions, increased hepatic enzymes, pyrexia; anaphylaxis, antibody formation.

Generic Availability:

NO

How Supplied:

Single-dose vial—1 (w. diluent, supplies)

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